Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy

Not Applicable

Completed

• Conditions: Insomnia; Anxiety; Depression
• Interventions: Behavioral: Transdiagnostic Internet-delivered Cognitive Behaviour Therapy; Behavioral: Brief Internet-Delivered Cognitive Behaviour Therapy for Insomnia

• Registration Number: NCT04512768
• Lead Sponsor: University of Regina

Brief Summary

Transdiagnostic Internet-delivered Cognitive Behaviour Therapy (ICBT) is an efficacious treatment option for anxiety and depression; however, not all patients benefit equally and some leave treatment before program completion. Comorbid symptoms of insomnia are extremely common among individuals seeking ICBT, yet sleep problems are rarely a primary focus of treatment in transdiagnostic ICBT despite insomnia being a known risk factor for anxiety and depression. This trial is designed to test whether an ICBT program for anxiety and depression can be improved by providing therapy for insomnia alongside the standard transdiagnostic program. For this randomized controlled trial, patients will be randomly assigned to receive either the standard ICBT program for anxiety and depression, which includes only brief supplementary information about sleep (n = 68), or a modified version that includes a lesson specifically on sleep (n = 132). The sleep lesson will introduce patients to two key behavioural strategies: sleep restriction and stimulus control, which previous research has demonstrated are effective at reducing insomnia. Patients will monitor their sleep throughout treatment and will complete measures of insomnia, anxiety and depression before treatment, at the end of the 8-week program, and 3 months after program conclusion to allow for a comparison of patient outcomes and completion rates between conditions. The acceptability of the new intervention will also be assessed by asking participants to provide feedback on the new materials and to complete measures of treatment satisfaction and working alliance.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-04
• Study First Submitted QC: 2020-08-10
• Study First Posted: 2020-08-14
• Study Start: 2020-09-09
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-20
• Last Update Posted: 2022-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 217

Inclusion Criteria

• Participants must reside in Saskatchewan
• Participants must have access to a computer and feel comfortable using the internet
• Participants must be willing to provide a medical contact (e.g., family doctor) in case of medical emergency
• Participants must endorse some symptoms of anxiety or depression
• Participants must also endorse significant symptoms of insomnia (Insomnia Severity Index score of 10 or above)

Exclusion Criteria

• High risk of suicide
• Unmanaged severe psychiatric illness (e.g., psychosis, mania)
• Severe alcohol or addictions problems that require referral
• High probability that another sleep disorder for which sleep restriction may be contraindicated is present (e.g., restless leg syndrome, sleep apnea, or sleep problems that are exclusively related to shift work)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard ICBT	Transdiagnostic Internet-delivered Cognitive Behaviour Therapy	Participants in the Standard ICBT condition will receive an 8-week transdiagnostic course for anxiety and depression called The Wellbeing Course, originally developed by Macquarie University, Australia.
Sleep-Enhanced ICBT	Brief Internet-Delivered Cognitive Behaviour Therapy for Insomnia	Participants in the Sleep-Enhanced ICBT condition will receive an 8-week transdiagnostic course for anxiety and depression called The Wellbeing Course, originally developed by Macquarie University, Australia. In addition, participants in the Sleep-Enhanced ICBT condition will also receive a newly developed lesson designed to target insomnia.
Sleep-Enhanced ICBT	Transdiagnostic Internet-delivered Cognitive Behaviour Therapy	Participants in the Sleep-Enhanced ICBT condition will receive an 8-week transdiagnostic course for anxiety and depression called The Wellbeing Course, originally developed by Macquarie University, Australia. In addition, participants in the Sleep-Enhanced ICBT condition will also receive a newly developed lesson designed to target insomnia.

Primary Outcome Measures

Name	Time	Method
Patient Health Questionnaire 9-item (PHQ-9)	Week 1 (pre-treatment), Week 8 (post-treatment), Week 20 (follow-up)	Change in depression symptoms from pre-treatment (Week 1) to post-treatment (8 weeks) and from pre-treatment to follow-up (20 weeks). The PHQ-9 is a 9-item self-report measure of symptoms of depression that produces a total depression severity score ranging from 0-27.
Generalized Anxiety Disorder (GAD-7)	Week 1 (pre-treatment), Week 8 (post-treatment), Week 20 (follow-up)	Change in anxiety symptom from pre-treatment (Week 1) to post-treatment (8 weeks) and from pre-treatment to follow-up (20 weeks). The GAD-7 is a 7-item self-report measure of symptoms of anxiety that produces a total anxiety severity score ranging from 0-21.
Insomnia Severity Index (ISI)	Week 1 (pre-treatment), Week 8 (post-treatment), Week 20 (follow-up)	Change in insomnia symptoms from pre-treatment (Week 1) to post-treatment (8 weeks) and from pre-treatment to follow-up (20 weeks). The ISI is a brief measure of insomnia comprised of 7 questions that ask about difficulties falling asleep, staying asleep, and waking too early, which respondents answer on a scale from 0 (None) to 4 (Very Severe), producing a score between 0 and 28.

Secondary Outcome Measures

Name	Time	Method
Treatment Satisfaction	Week 8 (post-treatment)	A treatment satisfaction questionnaire that includes questions about the patient's opinion of the program and the working alliance they developed with their therapist. Patients will also be asked whether they would recommend the treatment to others. Patients will then complete the Working Alliance Inventory-Short a 12-item measure of the therapeutic alliance.
Panic Disorder Severity Scale (PDSS)	Week 1 (pre-treatment), Week 8 (post-treatment), Week 20 (follow-up)	Change in symptoms of panic. The PDSS is a 7-item measure of common symptoms of panic disorder. Respondents answer each item on a 0-4 scale, producing a total score between 0 and 28.
Lesson Completion	Ongoing throughout treatment (Weeks 1-8)	The program website will record when patients access each lesson, providing a way to calculate the proportion of patients who complete each lesson and treatment overall.
Social Interaction Anxiety Scale and Social Phobia Scale - Short Form (SIAS-6/SPS-6)	Week 1 (pre-treatment), Week 8 (post-treatment), Week 20 (follow-up)	Change in symptoms of social anxiety. The SIAS-6/SPS-6 includes 12 items related to common symptoms of social anxiety that are summed to create a total score.

Trial Locations

Locations (1)

Online Therapy Unit, University of Regina; 🇨🇦 Regina, Saskatchewan, Canada